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    <udiDi>05407007962228</udiDi>
    <basicUdiDi>B-05407007962228</basicUdiDi>
    <tradeName>UltraGene Assay Stool parasites</tradeName>
    <deviceName>UltraGene Assay Stool parasites</deviceName>
    <manufacturerName>ADVANCED BIOLOGICAL LABORATORIES (ABL) S.A.</manufacturerName>
    <manufacturerSrn>LU-MF-000003752</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01050704</emdnCode>
    <emdnDescription>MULTIPLE PARASITES PANELS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10921737</reference>
    <placedOnMarketCountry>Luxembourg</placedOnMarketCountry>
    <lastUpdated>2026-09-26T11:11:27.553Z</lastUpdated>
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    <udiDi>05407007962211</udiDi>
    <basicUdiDi>B-05407007962211</basicUdiDi>
    <tradeName>UltraGene Assay Stool parasites</tradeName>
    <deviceName>UltraGene Assay Stool parasites</deviceName>
    <manufacturerName>ADVANCED BIOLOGICAL LABORATORIES (ABL) S.A.</manufacturerName>
    <manufacturerSrn>LU-MF-000003752</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01050704</emdnCode>
    <emdnDescription>MULTIPLE PARASITES PANELS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10921736</reference>
    <placedOnMarketCountry>Luxembourg</placedOnMarketCountry>
    <lastUpdated>2026-09-26T11:11:21.035Z</lastUpdated>
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    <udiDi>05407007962204</udiDi>
    <basicUdiDi>B-05407007962204</basicUdiDi>
    <tradeName>UltraGene Assay  SARS-CoV-2</tradeName>
    <deviceName>UltraGene Assay SARS-CoV-2</deviceName>
    <manufacturerName>ADVANCED BIOLOGICAL LABORATORIES (ABL) S.A.</manufacturerName>
    <manufacturerSrn>LU-MF-000003752</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11416284</reference>
    <placedOnMarketCountry>Luxembourg</placedOnMarketCountry>
    <lastUpdated>2026-09-26T11:11:11.244Z</lastUpdated>
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    <udiDi>05407007962198</udiDi>
    <basicUdiDi>B-05407007962198</basicUdiDi>
    <tradeName>UltraGene Assay FLU/HRSV</tradeName>
    <deviceName>UltraGene Assay FLU/HRSV</deviceName>
    <manufacturerName>ADVANCED BIOLOGICAL LABORATORIES (ABL) S.A.</manufacturerName>
    <manufacturerSrn>LU-MF-000003752</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070304</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10921785</reference>
    <placedOnMarketCountry>Luxembourg</placedOnMarketCountry>
    <lastUpdated>2026-09-26T11:11:04.743Z</lastUpdated>
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    <udiDi>05407007962181</udiDi>
    <basicUdiDi>B-05407007962181</basicUdiDi>
    <tradeName>UltraGene Assay Vesicular rash</tradeName>
    <deviceName>UltraGene Assay Vesicular rash</deviceName>
    <manufacturerName>ADVANCED BIOLOGICAL LABORATORIES (ABL) S.A.</manufacturerName>
    <manufacturerSrn>LU-MF-000003752</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10921715</reference>
    <placedOnMarketCountry>Luxembourg</placedOnMarketCountry>
    <lastUpdated>2026-09-26T11:11:01.471Z</lastUpdated>
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  <row>
    <udiDi>05407007962174</udiDi>
    <basicUdiDi>B-05407007962174</basicUdiDi>
    <tradeName>UltraGene Assay FLU/HRSV</tradeName>
    <deviceName>UltraGene Assay FLU/HRSV</deviceName>
    <manufacturerName>ADVANCED BIOLOGICAL LABORATORIES (ABL) S.A.</manufacturerName>
    <manufacturerSrn>LU-MF-000003752</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070304</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10921784</reference>
    <placedOnMarketCountry>Luxembourg</placedOnMarketCountry>
    <lastUpdated>2026-09-26T11:10:54.942Z</lastUpdated>
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  <row>
    <udiDi>05407007962167</udiDi>
    <basicUdiDi>B-05407007962167</basicUdiDi>
    <tradeName>UltraGene Assay Vesicular rash</tradeName>
    <deviceName>UltraGene Assay Vesicular rash</deviceName>
    <manufacturerName>ADVANCED BIOLOGICAL LABORATORIES (ABL) S.A.</manufacturerName>
    <manufacturerSrn>LU-MF-000003752</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10921716</reference>
    <placedOnMarketCountry>Luxembourg</placedOnMarketCountry>
    <lastUpdated>2026-09-26T11:10:45.155Z</lastUpdated>
  </row>
  <row>
    <udiDi>05407007962150</udiDi>
    <basicUdiDi>B-05407007962150</basicUdiDi>
    <tradeName>UltraGene Assay Viral meningitis</tradeName>
    <deviceName>UltraGene Assay Viral meningitis</deviceName>
    <manufacturerName>ADVANCED BIOLOGICAL LABORATORIES (ABL) S.A.</manufacturerName>
    <manufacturerSrn>LU-MF-000003752</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10921724</reference>
    <placedOnMarketCountry>Luxembourg</placedOnMarketCountry>
    <lastUpdated>2026-09-26T11:10:38.641Z</lastUpdated>
  </row>
  <row>
    <udiDi>05407007961986</udiDi>
    <basicUdiDi>B-05407007961986</basicUdiDi>
    <tradeName>UltraGene Assay Viral meningitis</tradeName>
    <deviceName>UltraGene Assay Viral meningitis</deviceName>
    <manufacturerName>ADVANCED BIOLOGICAL LABORATORIES (ABL) S.A.</manufacturerName>
    <manufacturerSrn>LU-MF-000003752</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10921725</reference>
    <placedOnMarketCountry>Luxembourg</placedOnMarketCountry>
    <lastUpdated>2026-09-26T11:10:35.214Z</lastUpdated>
  </row>
  <row>
    <udiDi>05407007961955</udiDi>
    <basicUdiDi>B-05407007961955</basicUdiDi>
    <tradeName>UltraGene Assay Respiratory pathogens 21</tradeName>
    <deviceName>UltraGene Assay Respiratory pathogens 21</deviceName>
    <manufacturerName>ADVANCED BIOLOGICAL LABORATORIES (ABL) S.A.</manufacturerName>
    <manufacturerSrn>LU-MF-000003752</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10921703</reference>
    <placedOnMarketCountry>Luxembourg</placedOnMarketCountry>
    <lastUpdated>2026-09-26T11:10:28.375Z</lastUpdated>
  </row>
  <row>
    <udiDi>05407007961948</udiDi>
    <basicUdiDi>B-05407007961948</basicUdiDi>
    <tradeName>UltraGene Assay Respiratory pathogens 21</tradeName>
    <deviceName>UltraGene Assay  Respiratory pathogens 21</deviceName>
    <manufacturerName>ADVANCED BIOLOGICAL LABORATORIES (ABL) S.A.</manufacturerName>
    <manufacturerSrn>LU-MF-000003752</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10921702</reference>
    <placedOnMarketCountry>Luxembourg</placedOnMarketCountry>
    <lastUpdated>2026-09-26T11:10:18.031Z</lastUpdated>
  </row>
  <row>
    <udiDi>05407007960590</udiDi>
    <basicUdiDi>B-05407007960590</basicUdiDi>
    <tradeName>UltraGene Assay Combo 4 Screening</tradeName>
    <deviceName>UltraGene Assay Combo 4 Screening V2.X</deviceName>
    <manufacturerName>ADVANCED BIOLOGICAL LABORATORIES (ABL) S.A.</manufacturerName>
    <manufacturerSrn>LU-MF-000003752</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070304</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>150B1000</reference>
    <placedOnMarketCountry>Luxembourg</placedOnMarketCountry>
    <lastUpdated>2026-09-26T11:10:11.174Z</lastUpdated>
  </row>
  <row>
    <udiDi>05407007960576</udiDi>
    <basicUdiDi>B-05407007960576</basicUdiDi>
    <tradeName>UltraGene Assay Combo 4 Screening</tradeName>
    <deviceName>UltraGene Assay Combo 4 Screening V2.X</deviceName>
    <manufacturerName>ADVANCED BIOLOGICAL LABORATORIES (ABL) S.A.</manufacturerName>
    <manufacturerSrn>LU-MF-000003752</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070304</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>150B50</reference>
    <placedOnMarketCountry>Luxembourg</placedOnMarketCountry>
    <lastUpdated>2026-09-26T11:10:07.733Z</lastUpdated>
  </row>
  <row>
    <udiDi>05407007960569</udiDi>
    <basicUdiDi>B-05407007960569</basicUdiDi>
    <tradeName>UltraGene Assay SARS-CoV-2 PrimeChek</tradeName>
    <deviceName>UltraGene Assay SARS-CoV-2 PrimeChek V3</deviceName>
    <manufacturerName>ADVANCED BIOLOGICAL LABORATORIES (ABL) S.A.</manufacturerName>
    <manufacturerSrn>LU-MF-000003752</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>169C96_D</reference>
    <placedOnMarketCountry>Luxembourg</placedOnMarketCountry>
    <lastUpdated>2026-09-26T11:10:00.884Z</lastUpdated>
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  <row>
    <udiDi>05407007960545</udiDi>
    <basicUdiDi>B-05407007960545</basicUdiDi>
    <tradeName>UltraGene Assay SARS-CoV-2 PrimeChek</tradeName>
    <deviceName>UltraGene Assay SARS-CoV-2 PrimeChek V3</deviceName>
    <manufacturerName>ADVANCED BIOLOGICAL LABORATORIES (ABL) S.A.</manufacturerName>
    <manufacturerSrn>LU-MF-000003752</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>169C1000</reference>
    <placedOnMarketCountry>Luxembourg</placedOnMarketCountry>
    <lastUpdated>2026-09-26T11:09:50.577Z</lastUpdated>
  </row>
  <row>
    <udiDi>05407007960538</udiDi>
    <basicUdiDi>B-05407007960538</basicUdiDi>
    <tradeName>UltraGene Assay SARS-CoV-2 PrimeChek</tradeName>
    <deviceName>UltraGene Assay SARS-CoV-2 PrimeChek V3</deviceName>
    <manufacturerName>ADVANCED BIOLOGICAL LABORATORIES (ABL) S.A.</manufacturerName>
    <manufacturerSrn>LU-MF-000003752</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>169C50</reference>
    <placedOnMarketCountry>Luxembourg</placedOnMarketCountry>
    <lastUpdated>2026-09-26T11:09:43.716Z</lastUpdated>
  </row>
  <row>
    <udiDi>05407007960521</udiDi>
    <basicUdiDi>B-05407007960521</basicUdiDi>
    <tradeName>DeepChek® Assay Whole Genome HIV-1 Genotyping</tradeName>
    <deviceName>DeepChek® Assay Whole Genome HIV-1 Genotyping V1.X</deviceName>
    <manufacturerName>ADVANCED BIOLOGICAL LABORATORIES (ABL) S.A.</manufacturerName>
    <manufacturerSrn>LU-MF-000003752</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105030108</emdnCode>
    <emdnDescription>HIV 1 GENOTYPING - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>170A24</reference>
    <placedOnMarketCountry>Luxembourg</placedOnMarketCountry>
    <lastUpdated>2026-09-26T11:09:40.276Z</lastUpdated>
  </row>
  <row>
    <udiDi>05407007960491</udiDi>
    <basicUdiDi>B-05407007960491</basicUdiDi>
    <tradeName>DeepChek® Assay 13-Plex KB Drug Susceptibility Testing</tradeName>
    <deviceName>DeepChek® Assay 13-Plex KB Drug Susceptibility Testing V1.X</deviceName>
    <manufacturerName>ADVANCED BIOLOGICAL LABORATORIES (ABL) S.A.</manufacturerName>
    <manufacturerSrn>LU-MF-000003752</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010799</emdnCode>
    <emdnDescription>MYCOBACTERIA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>128A24</reference>
    <placedOnMarketCountry>Luxembourg</placedOnMarketCountry>
    <lastUpdated>2026-09-26T11:09:33.431Z</lastUpdated>
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  <row>
    <udiDi>05407007960477</udiDi>
    <basicUdiDi>B-05407007960477</basicUdiDi>
    <tradeName>UltraGene Assay SARS-CoV-2 VOC Screening &amp; Determination</tradeName>
    <deviceName>UltraGene Assay SARS-CoV-2 VOC Screening &amp; Determination V1.X</deviceName>
    <manufacturerName>ADVANCED BIOLOGICAL LABORATORIES (ABL) S.A.</manufacturerName>
    <manufacturerSrn>LU-MF-000003752</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>176A50</reference>
    <placedOnMarketCountry>Luxembourg</placedOnMarketCountry>
    <lastUpdated>2026-09-26T11:09:22.667Z</lastUpdated>
  </row>
  <row>
    <udiDi>05407007960439</udiDi>
    <basicUdiDi>B-05407007960439</basicUdiDi>
    <tradeName>UltraGene Assay SARS-CoV-2 Universalis</tradeName>
    <deviceName>UltraGene Assay SARS-CoV-2 Universalis V2.X</deviceName>
    <manufacturerName>ADVANCED BIOLOGICAL LABORATORIES (ABL) S.A.</manufacturerName>
    <manufacturerSrn>LU-MF-000003752</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>169B1000</reference>
    <placedOnMarketCountry>Luxembourg</placedOnMarketCountry>
    <lastUpdated>2026-09-26T11:09:11.753Z</lastUpdated>
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